DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 07/07/26 have been entered in the case. Claims 1-7, 10-12 & 21-23 are pending for examination and claims 13-20 are withdrawn; claims 8-9 are cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 10-12 & 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “wherein the delivery catheter is free of a source of chemical ablation formulation; ...., wherein the denervating or ablating comprises delivering the energy to the target tissue in the absence of delivering a chemical ablation formulation to the target tissue...” in claim 1 is failing to comply with the written description requirement.
According to the para [0087] in the original specification, it states that: ... Cooling a needle electrode can include flowing a coolant or a liquid that enhances RF delivery thought the needle before, during, or after radiofrequency delivery (e.g., a chemical formulation as described herein or a different liquid composition). In one embodiment of external cooling of electrodes (open-loop), the chemical formulation described herein can replace the active cooling fluids. The disclosed formulations can be used not only for cooling electrodes, but also used for chemical ablation of the target tissue. The formulations can in some embodiments diffuse and permeate into the nerve tissue uniformly, and they can ablate the nerves in adventitia uniformly in the body lumen. Therefore, the chemical ablation formulation can be delivered during, before, and/or after the energy ablations.
In addition, the original specification also states that: The chemical formulation and/or energy delivered to the target tissues can reduce body weight, reduce high blood pressure, reduce A1C, reduce blood glucose level, reduce body waist fat tissue, or a combination thereof., see paras [0019, 0021-0025, 0086-0087...].
Based on the statement in paragraphs [0019, 0021-0025, 0086-0087, ...] above, the chemical ablation formulation is delivered during, before, and/or after the energy ablations. Therefore, the claimed limitation above is contradicted by the statement in paragraph [0087] of the original specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 10-12 & 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0015264) in view of Wang (US 2015/0272666).
Regarding claims 1 & 23, Wang’264 discloses a method for treating at least one disease (hypertension, pulmonary arteries, diabetes, obesity, heart failure…, see abstract) comprising treating at least two different target tissues in at least two different body lumens (bronchitis airway in Figs. 5A-5B, renal artery in Fig. 5B, gastric artery in Fig. 10A, hepatic plexuses in Fig. 10B, or stomach in Fig. 11), the method comprising:
performing a treatment procedure on a body lumen that is a first body lumen 502 in Fig. 5C, the treatment procedure comprising:
inserting a delivery catheter 106 into the body lumen 502 (extra renal artery, in Fig. 5C), wherein the delivery catheter comprises a catheter shaft 106, a balloon at a distal end portion of the shaft, and an inflation lumen in fluid communication with an interior of the balloon, see Figs. 7-9C for double/triple balloons;
inflating the balloon to center the distal end of the shaft in the body lumen, see Fig. 5C;
denervating or ablating target tissue of the body lumen with the delivery catheter comprising delivering an amount of energy or heat (paras [0050, 0090, 0097, 0133]) to the target tissue effective to injure or damage the target tissue to relieve a disease symptom;
Note: with aspect to the limitations, i.e., wherein the delivery catheter is free of a source of chemical ablation formulation; wherein the denervating or ablating comprises delivering the energy to the target tissue in the absence of delivering a chemical ablation formulation to the target tissue, as mentioned above, these limitations involve 112, 1st paragraph issue. For examining purpose, these limitations temporary ignore.
Based on the paras [0019, 0021-0025, 0086-0087, ...] of the original specification (equivalent to US 2022/0233238), the original specification has described that: the chemical formulation and/or energy delivered to the target tissues can reduce body weight, reduce high blood pressure, reduce A1C, reduce blood glucose level, reduce body waist fat tissue, or a combination thereof. Similarly, the prior art Wang’264 states that: amounts of the formulation and/or energy are effective to injure or damage tissue, nerves, and nerve endings in order to relieve disease symptoms, see abstract, para [0133]. Therefore, for purpose of examining, the Examiner interprets that: the method for treating at least one of the diseases comprising the steps of wherein the delivery catheter is including source of chemical ablation formulation; wherein the denervating or ablating comprises delivering the energy to the target tissue comprising a step of delivering a chemical ablation formulation to the target tissue.
Wang’264 further discloses the method comprising:
deflating the balloon, (para [0097], By the end of the treatment time, the balloon was deflated and withdrawn, or placed into another artery site if required for the next treatment); and
removing the delivery catheter from the body lumen, (para [0097], By the end of the treatment time, the balloon was deflated and withdrawn, or placed into another artery site if required for the next treatment); and
performing the treatment procedure on a second body lumen, e.g., a main bronchus 21 in Figs. 5A-5B) or a gastric artery 360 in Fig. 10A or hepatic plexuses 345 in Fig. 10B, or stomach in Fig. 11 that different than the first body lumen 502, wherein the first body lumen and the second body lumen belong to different classes of body lumens chosen from renal arteries, gastric arteries, hepatic arteries, pulmonary arteries, celiac arteries, gastroduodenal arteries.
Note: Wang’264 discloses a device and method for treating multiple diseases, i.e., hypertension, pulmonary arteries, diabetes, obesity, heart failure, end-state renal disease... and the treatment in different body lumens, see Figs. 5A, 5C, 10A-11. Wang’264 further states that: after each treatment, balloons were partially deflated and pulled back to a pre-defined distance to avoid overlapping treatment with the next treatment location. Treatment was then repeated, para [0152]; following each treatment, ballons are partially deflated and moved to other locations for additional treatments, para [0155]. Based on the statements above, a person skilled in the art would recognize that the performing the treatment procedure on a second body lumen that different classes of the first body lumen for purpose of treating two or more diseases in a patient.
Wang’264 does not disclose that the energy comprises radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof.
Wang’666 discloses a method of treating at least one disease (hypertension, pulmonary arteries, diabetes, obesity, heart failure…, see abstract) comprising treating at least two different target tissues in at least two different body lumens (bronchitis airway in Figs. 2A-2B, renal artery in Fig. 2C, pulmonary artery, Fig. 4), the method comprising: inserting a delivery catheter into the body lumen; inflating the balloon to center the distal end of the shaft in the body lumen, see Fig. 2A-4;
denervating or ablating target tissue of the body lumen with the delivery catheter comprising delivering an amount of energy (see abstract) to the target tissue effective to injure or damage the target tissue to relieve a disease symptom; wherein the energy comprises radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof, paras [0037, 0051, 0072].
Since Wang’264 and Wang’666 are both from the same field of endeavor, the purpose disclosed by Wang’666 would have been recognized in the pertinent art of Wang’264.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method of Wang’264 with including method of using radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof to injury or damage the tissue/nerve, as taught by Wang’666, in order to have a benefit of symptom relive.
Regarding claim 2, Wang’264 discloses that wherein the first body lumen and the second body lumen belong to different classes of body lumens chosen from renal arteries (Fig. 5C), gastric arteries (Fig. 10A), hepatic arteries (Fig. 10B).
Regarding claim 3, Wang’264 discloses that wherein the at least one disease comprises: at least two diseases; or at least three diseases; or at least four diseases, see the rejection in claim 2 above.
Regarding claim 4, Wang’264 discloses that wherein the disease is chosen from hypertension, pulmonary hypertension, diabetes, obesity, metabolic syndrome, heart failure, myocardial infarction, atherosclerosis, coronary artery disease (CAD), peripheral vascular disease (PAD), end-stage renal disease, digestive disease, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), urological disease, cancers, tumors, pain, rheumatoid arthritis (RA), asthma, chronic obstructive pulmonary disease (COPD), and a combination thereof, see abstract and para [0014].
Regarding claim 5, Wang’264 discloses that wherein the at least one disease comprises at least two diseases comprising renal hypertension and diabetes, or renal hypertension and obesity, or diabetes and obesity, or a combination thereof, paras [0014-0015, 0024, 0061].
Regarding claim 6, Wang’264 discloses that wherein the relieving the disease symptom comprises reducing blood pressure (hypertension), reducing blood glucose level and A1C, reducing body weight (obesity), reducing restenosis, reducing liver fat, and reducing pain, or a combination thereof, see abstract, paras [0014-0015, 0024, 0061].
Regarding claim 7, Wang’264 discloses that wherein the delivery catheter comprises a chemical infusion delivery catheter, see Figs. 3A-4B, 6-9C; denervating or ablating target tissue of the body lumen with the delivery catheter comprising delivering an amount of formulation (paras [0095, 0097]) to the target tissue.
Regarding claim 10, Wang’264 discloses that wherein the formulation comprises one or more ingredients chosen from water, saline, hypertonic saline, phenol, methanol, ethanol, absolute alcohol, isopropanol, propanol, butanol, isobutanol, ethylene glycol, glycerol, acetic acid, lactic acid, propyl iodide, isopropyl iodide, ethyl iodide, methyl acetate, ethyl acetate, ethyl nitrate. isopropyl acetate, ethyl lactate, lipiodol, urea, and derivatives and combinations thereof, paras [0016-0017].
Regarding claim 11, Wang’264 discloses that wherein the formulation comprises ethanol, paras [0016-0017].
Regarding claim 12, Wang’264 discloses that wherein the formulation comprises an azeotrope, paras [0021-0022].
Regarding claim 21, Wang’264 discloses that wherein the first body lumen or the second body lumen comprises a common hepatic artery 345, see Fig. 10B, and para [0024].
Regarding claim 22, Wang’264 discloses in paras [0152 & 0155] that: after each treatment, balloons were partially deflated and pulled back to a pre-defined distance to avoid overlapping treatment with the next treatment location. Treatment was then repeated; following each treatment, ballons are partially deflated and moved to other locations for additional treatments. Therefore, a person skilled in the art would recognize that the treatment procedure is performed on both the first body lumen and the second body lumen in a single procedure.
Response to Arguments
Applicant's arguments filed 07/07/26 have been fully considered but they are not persuasive.
1) Applicant states that the amended claim 1 recites that the delivery catheter “... is free of a source of chemical ablation formulation ...” and that the denervating or ablating is performed “... in the absence of delivering a chemical ablation formulation to the target tissue ...” Meanwhile, the paras [0152 & 0155] in Waing’264 (or Wang I) describe ablation performed by delivering acetic acid and absolute ethanol, which is performed including a chemical ablation formulation.
In response, as mentioned above, these limitations above involve 112, 1st paragraph issue.
Based on the paras [0021-0025, 0086-0087, ...] of the original specification (equivalent to US 2022/0233238), the original specification has described that: the chemical formulation and/or energy delivered to the target tissues can reduce body weight, reduce high blood pressure, reduce A1C, reduce blood glucose level, reduce body waist fat tissue, or a combination thereof.
The para [0065] FIG. 10 is a bar chart demonstrating norepinephrine (NE) reduction following renal denervation from ethanol- vs. control-treated groups, in accordance with various embodiments.
[0066] FIG. 11 is a histopathologic image demonstrating severed renal nerves necrosis (as shown by black arrows) following ethanol treatment, in accordance with various embodiments.
[0067] FIG. 12 is a bar chart demonstrating norepinephrine (NE) reduction following hepatic denervation from ethanol- vs. control-treated groups, in accordance with various embodiments.
[0150] A rapid exchange (RX) needle balloon delivery catheter can be used in an ablation procedure via blood vessel. The infusion lumen and needles of the catheter can be prefilled with the ablation agent of ethanol from its port 704,
The paras [0184-0188, 0190, 0192-0194, 0198, 0200] have described that the delivery catheter includes the chemical ablation formulation, i.e., ethanol.
Based on multiples paragraphs as mentioned above, the current invention includes the delivery catheter includes the chemical ablation formulation, i.e., ethanol.
Similarly, the prior art Wang’264 states that: amounts of the formulation and/or energy are effective to injure or damage tissue, nerves, and nerve endings in order to relieve disease symptoms, see abstract, para [0133].
Therefore, for purpose of examining, the Examiner interprets that: the method for treating at least one of the diseases comprising the steps of wherein the delivery catheter is including source of chemical ablation formulation; wherein the denervating or ablating comprises delivering the energy to the target tissue comprising a step of delivering a chemical ablation formulation to the target tissue
2) Applicant argues that Wang II (Wang’666) does not cure the deficient of Wang I (Wang’264). Wang II teaches that energy modalities such as RF, microwaves, laser ultrasound and high-intensity focused ultrasound can be used to ablate tissue.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the original specification has described in paras [0019, 0021-0025, 0086-0087, ...] that: the chemical formulation and/or energy delivered to the target tissues can reduce body weight, reduce high blood pressure, reduce A1C, reduce blood glucose level, reduce body waist fat tissue, or a combination thereof.
Similarly, as mentioned in multiple times above, Wang I (Wang’264) has described the method of performing the recited treatment procedure on a first body lumen and then performing the same treatment procedure on a second body lumen on a different class. Wang I clearly state that
The prior art Wang I states that: amounts of the formulation and/or energy are effective to injure or damage tissue, nerves, and nerve endings in order to relieve disease symptoms, see abstract; the energy or heat can enhance the injury/damage/elimination effect by accelerating the reaction rate between the formulation and tissues, paras [0050, 0133]. Wang’264 further states that using the catheter to infuse the formulation and/or heat to the tissue of the body lumen adjacent to the nerves, paras [0141-0148].
Although Wang I does not specifically to mention of using what kinds of energy such as: RF energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy. It is well-known in the art to recognize that the method of using different kind of energies listed above that related to the energy and/or heat to damage, injure tissue, nerve. Similarly, the prior art Wang’666 teaches that the amounts of formulations and/or energy are effective to injury or damage the tissues to have a benefit of symptom relieve. The energy can be radiofrequency, cryoablation, microwave, laser, ultrasound, and/or high-intensity focused ultrasound energies... , see para [0037].
Giving such a teaching by Wang II (Wang’666), a person having ordinary skill in the art would have easily recognizes that modifying the method of Wang I with providing a method of using energy such as radio frequency, cryoablation, microwave, laser, ultrasound, and/or high-intensity focused ultrasound energies, as taught by Wang I, in order to have a benefit of symptom relieve.
3) Applicant argues that Wang’264 (or Wang I)’s embodiment directed to different body lumens are presented as distinct, standalone embodiments for distinct diseases.
In response, the Applicant should read the entire document in Wang I as a whole, rather than pointing to a specific part in certain paragraphs in the prior art Wang I and stating that the prior art fails to meet the limitations of claim 1.
Wang’264 clearly shows in different figures 5A-5C, 10A-11 that a method of using energy-based procedure is performed on body lumens from different classes, i.e., bronchial tree; extra renal artery, gastric artery, hepatic plexuses, duodenum. Wang further states in para [0152] that: after each treatment, balloons were partially deflated and pulled back to a pre-defined distance to avoid overlapping treatment with the next treatment location. Treatment was then repeated; In para [0155] states that: following each treatment, ballons are partially deflated and moved to other locations for additional treatments.
Wang’264 describes in different embodiment-figures 5A-5C, 10A-11 that the method can be treated in different area but does not limit that the treatment can be treated in a single treatment procedure. In addition, Wang’264 clearly states in para [0152] that the treatment can be repeated. Wang states in para [0155] that: following each treatment, balloons are partially deflated and move to other locations for additional treatment (emphasis added).
Based on the statement in paras [0152 & 0155] above, Wang’264 can be used the method of using energy-based procedure in different body lumens from different classes, a person skilled in the art would recognize that the method can be performed sequentially on different body lumens (e.g., moved to other locations for additional treatments, as mentioned in para [0155]) for treating same person who having multiple symptoms, i.e., hypertension, diabetes, obesity, heart failure...
4) Applicant further states that: Wang II does not describe performing the recited treatment procedure on a first body lumen and then performing the same treatment procedure on a second body lumen on a different class.
In response, this clamed feature has been described in the prior art Wang I. Please see the rejection in the claim 1 above for more details.
5) Applicant argues that the claim 22 depends on claim 1 recites that “the treatment procedure is performed on both the first body lumen and the second body lumen in a single procedure.
In response, similar to the response to the argument in part 3) above. Wang I (Wang’264) describes in different embodiment-figures 5A-5C, 10A-11 that the method can be treated in different area but does not limit that the treatment can be treated in a single treatment procedure. In addition, Wang’264 clearly states in para [0152] that the treatment can be repeated. Wang states in para [0155] that: following each treatment, balloons are partially deflated and move to other locations for additional treatment (emphasis added).
Based on the statement in paras [0152 & 0155] above, Wang I (Wang’264) has described the method of performing on both the fist body lumen and the second body lumen in a single procedure (e.g., the treatment can be repeated, para [0152]; following each treatment, balloons are partially deflated and move to other locations for additional treatment, para [0155])
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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